Tranexamic Acid with Intensive Blood Pressure Management in Ultra-Early Intracerebral Hemorrhage (NCT06760078) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Tranexamic Acid with Intensive Blood Pressure Management in Ultra-Early Intracerebral Hemorrhage
China532 participantsStarted 2024-12-31
Plain-language summary
This is a prospective, multicenter, randomized, quadruple-blind, placebo-controlled study. This study aims to estimate the safety and efficacy of intravenous tranexamic acid (TXA) combined with intensive blood pressure lowering in ultra-early spontaneous intracerebral hemorrhage (ICH).
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Age between 18 to 80 years old;
✓. A definite diagnosis of supratentorial brain parenchymal hemorrhage by non-contrast cranial CT scan;
✓. Hemorrhage volume less than 40 mL, as calculated using the ABC/2 method, with ultra-early hemorrhage growth (uHG) 10 mL/h or higher;
✓. A clear time of symptom onset, and the randomization must occur within 2 hours from the onset;
✓. At least two measurements of systolic blood pressure that are ≥150 mmHg and \<220 mmHg, with at least a 2-minute interval between measurements.;
✓. Baseline NIHSS of 8 or higher, or unilateral limb muscle strength of 0-3 grades;
✓. GCS score greater than 8;
✓. The patient or their legal representative has signed an informed consent form.
Exclusion criteria
✕. Pre-illness mRS \> 2;
✕. Primary thalamic hemorrhage or intracerebral hemorrhage that has extended into the ventricles;
✕. Scheduled for surgical intervention (i.e., hematoma evacuation, craniectomy);
✕. Secondary ICH from tumors, AVMs, and aneurysms;